ISPE Assembles FDA & MHRA Experts to Discuss Pharmaceutical Supply Chain Trends, Challenges, & Solutions

19 August, 2020

ISPE announced its 2020 ISPE Asia Pacific Pharma Manufacturing Virtual Conference & Executive Forum 21–23 September 2020. Now in its third year, this event brings together leaders from various offices under the Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) to discuss key trends, best practices, and regulatory perspectives for maintaining pharmaceutical supply chain continuity and compliance during and after the global pandemic.

“Manufacturing partners across geographic regions are navigating this new normal under stressful conditions exacerbated by increased demand for active pharmaceutical ingredients and essential medicines, new supply chain challenges, and the critical global focus on compliance and quality,” said Frances Zipp, President & CEO, Lachman Consultant Services, Inc., and Conference Co-Chair. “To truly continue to succeed as an industry, we must knowledge share and problem-solve together to mitigate the pharmaceutical supply chain impact of COVID-19 and proactively prepare for continued future success. That is what we will do during this collaborative event.”

As pharmaceutical manufacturers reprioritize production due to changing and increased product demand, many don’t have alternate suppliers for critical components. This has been a game-changer as they not only have to identify new suppliers, but they must also qualify these components to ensure they understand impact on process, and that quality meets the required standards. During this event, attendees will have the chance to ask questions to industry experts and regulators and hear what other companies are doing to overcome pandemic-driven challenges.


Featured Regulatory Speakers:

Carmelo Rosa, PsyD
Director, Division of Drug Quality I
FDA/CDER/OC/OMQ
Letitia Robinson, PhD
Country Director, India Office
FDA/ORA
Placeholder Person Graphic
Mr. Jose Melendez, Eng
Senior Automation Engineer
Global Automation Partners
Christopher T. Middendorf
International Relations Specialist / Diplomat At FDA
FDA/OC
Sarah McMullen, PhD
Deputy Director
FDA
Aditi S. Thakur
Acting Quality Assessment Lead
FDA/CDER/OPQ/OPF
Emily Thakur, CDR
Team Leader, Drug Shortages Staff
FDA
David Churchward
Deputy Unit Manager, Inspectorate Strategy & Innovation
MHRA

The 2020 ISPE Asia Pacific Pharma Manufacturing Virtual Conference & Executive Forum has been reimagined into a virtual experience that will immerse attendees in actionable, interactive discussions around strategies to make their manufacturing operations more agile, compliant, and resilient to disruption. Education sessions feature case studies and dedicated Q&A time with experts representing FDA, MHRA, local health authorities, Pfizer, Biocon, and more.

View Agenda & Register